NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	181587-01-9
Chemical Name	5-Amino-1-(2,6-dichloro-4-trifluoromethylphenyl)-4-ethylsulfinyl-1H-pyrazole-3-carbonitrile [ethiprole]
Substance ID	m-nite-181587-01-9_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)
Sample SDS by MHLW (External link)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Classification not possible	- -	-	-	It contains neighboring nitrogen atoms (pyrazole ring), but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It contains neighboring nitrogen atoms (pyrazole ring), but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound which contains fluorine, oxygen, and chlorine, and the oxygen is chemically bonded to the elements (S) other than carbon or hydrogen, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	From a reported LD50 value of > 7,080 mg/kg for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From a reported LD50 value of > 2,000 mg/kg for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	From a reported LC50 value (4 hours) of > 5.21 mg/L for rats (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)), it was classified as "Not classified." Besides, a reference value of dust was applied because test substance is a solid.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported that in a skin irritation test using rabbits applied 500 mg this substance, it was not irritating due to no skin reaction observed during a 72-hour observation period (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is reported that in an eye irritation test using rabbits applied 100 mg this substance, it was not irritating due to no irritation reaction observed in cornea and iris during an observation period from 1 to 72 hours (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	It is reported that in a maximization test using guinea pigs, this substance was not a skin sensitizer due to no sensitization reaction observed after induction and challenge (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). Because the above test is a GLP compliance test corresponding to OECD TG 406, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test in mouse bone marrow cells and an unscheduled DNA synthesis test in rat hepatocytes were negative. As for in vitro, a bacterial reverse mutation test, a chromosomal aberration test in cultured mammalian cells and cultured human peripheral blood lymphocytes, and a gene mutation test in cultured mammalian cells were negative. (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2004); EPA Pesticide Fact Sheet (2012)) Therefore, the substance was classified as "Classification not possible" in accordance with Guidance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	As for experimental animals, in a carcinogenicity test in oral administration (in the diet) of this substance in rats for two years, or in mice for 1.5 years, increases in thyroid follicular epithelial adenoma and hepatocellular adenoma were observed in male rats at the highest dose (250 ppm) although it is not significant. In mice, a slightly increased incidence of hepatocellular adenoma (6/50 animals, significant at 5%) was found in females at the highest dose (300 ppm) (Pesticide abstract (2015), EPA Pesticide Fact Sheet (2012)). Although increases of thyroid tumor in rats and liver tumor in mice were observed in the carcinogenicity test, it is difficult to consider that a mechanism of both is through genotoxicity, and Food Safety Commission of Japan concluded that a threshold could be set in the assessment. (Pesticide evaluation report, Food Safety Commission of Japan (2014)) As existing classification result by the international organization, EPA classified the substance in S (Suggestive Evidence of Carcinogenicity) (EPA Pesticide Fact Sheet (2012), EPA 2014 Annual Cancer Report (Access on January 2015)). As above, from the existing classification result, the substance was classified in Category 2 in this hazard class in accordance with Guidance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	As for experimental animals, in a two-generation breeding toxicity test using rats in oral administration (in the diet), in parent animals, both P (F0) and F1 generation showed weight gain reduction (females), effects on the liver or thyroid (increased weight, hepatocellular hypertrophy/hypertrophy of thyroid follicular epithelial cells) in both males and females, or in either males or females at a high dose (500 ppm), and increased liver weight was also observed at a middle dose (75 ppm). However, F1 and F2 offspring showed lower body weight during a nursing period, decreased organ weight (thymus, spleen, kidney, and brain) in a necropsy at weaning at a high dose (500 ppm), and F1 offspring in a high dose group showed delayed sexual maturation (delay in acquisition of preputial separation and vaginal patency) as well (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). As above, offspring showed findings indicating growth reduction and delayed sexual maturation at a dose where general toxicity effects were observed in parent animals. However, toxic effects on sexual function and fertility were not found in parent animals (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014); EPA Pesticide Fact Sheet (2012)). On the other hand, as a teratogenicity test, this substance was administered by gavage to pregnant rats at 3 to 30 mg/kg/day on day 6 to 20 of gestation, or to pregnant rabbits at 0.25 to 4.0 mg/kg/day on day 6 to 28 of gestation. It is written that in rats, weight gain reduction, decreased food consumption, clarified hepatic lobules in maternal animals, and skeletal variations (increased incidences of dumbbell body of the thoracic vertebra and unossification of the first metatarsal bone) in fetuses were observed at 30 mg/kg/day (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). In rabbits, weight gain reduction, decreased food consumption, increased incidence of abortion in maternal animals and skeletal variations (increased incidences of incomplete ossification/unossification of the first metacarpal bone, unossification of forelimb fourth and fifth middle phalanx) in fetuses were found at 2.0 mg/kg/day or higher (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). However, it is reported that this substance did not show teratogenicity in either rats or rabbits (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014)). Moreover, it is also written in the US EPA report that skeletal variations or incomplete ossification were observed in fetuses at doses where maternal toxicity occurred (EPA Pesticide Fact Sheet (2012)). As above, in the breeding test in rats, offspring showed lower body weight and decreased organ weight by weaning at a dose where general toxicity occurred in parent animals, and F1 offspring showed delayed sexual maturation as well. All of these findings were considered to reflect growth reduction by weaning. However, it was judged that delayed sexual maturation is a finding that should be a rationale for the classification as developmental toxicity effects. In the teratogenicity test, slight developmental effects of incomplete ossification and skeletal variations only were observed as developmental effects. From the above, because growth reduction and delayed sexual maturation were found in the next generation at a dose where toxicity occurred in parent animals in the breeding test in rats, the substance was classified in Category 2 in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There are no human data on this substance. As for experimental animals, the following was observed (Pesticide abstract (2015); Pesticide evaluation report, Food Safety Commission of Japan (2014); EPA Pesticide Fact Sheet (2012)): decreased landing foot splay and decreased spontaneous motility in oral administration (100 mg/kg, corresponding to Category 1) in rats; no abnormal findings in dermal administration (LD50 > 2,000 mg/kg) in rats; hunched posture, eyelid ptosis, decreased respiratory rate, incoordination, tremor, and lethargy in inhalation exposure (LC50 > 5.21 mg/L, above Category 2) in rats; decreased grooming, increased grip strength of forelimb and hindlimb, closed eyelids, hunched posture, decreased landing foot splay, decreased spontaneous motility at 250 mg/kg corresponding to Category 1, closed eyelids and decreased arousal level at 35 mg/kg in oral administration neurotoxicity test in rats; and convulsion in general pharmacological test in mice in oral administration (120 mg/kg, corresponding to Category 1). From the above, because this substance has neurotoxicity, it was classified in Category 1 (nervous system).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, thyroid), Category 2 (blood system, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no report in humans. As for experimental animals, in 90-day diet administration toxicity test using rats, effects on the liver (centrilobular hepatocellular hypertrophy and so on) and effects on the thyroid (hypertrophy/hyperplasia of thyroid follicular epithelial cells and so on) in males and females, and effects on blood in females (decreases in hemoglobin content and hematocrit and so on) were observed in dose groups of 500 ppm (males 30.5 mg/kg/day, females: 37.6 mg/kg/day) within a range of Category 2 or higher (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). In a 90-day diet administration toxicity test using dogs, effects on the liver (males: centrilobular hepatocellular hypertrophy, females: increased alkaline phosphatase activity) were observed in males in dose groups of 90 ppm (males: 3.2　mg/kg/day) or higher, and in females in a 200 ppm dose group (females: 8.5 mg/kg/day) within a range of Category 1 (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). In a 2-year diet administration combined chronic toxicity/carcinogenicity test using rats, the followings was observed (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)): effects on the liver (males: fibrosis of bile duct and so on, females: hyperplasia of bile duct and so on) in males and females, and effects on the thyroid (deposit of colloidal minerals and so on) in females in dose groups of 75 ppm (males: 3.2 mg/kg/day, females: 4.4 mg/kg/day) within a range of Category 1 or higher; effects on the kidney (males: progressive chronic nephrosis, females: arteritis/periarteritis) in males and females in a 250 ppm dose group (males: 10.8 mg/kg/day, females: 14.7 mg/kg/day) within a range of Category 2. In a 18-month diet administration carcinogenicity test using mice, effects on the liver (clear cell foci of altered hepatocytes and so on) were found in males in a 300 ppm dose group (males: 50.8 mg/kg/day) within a range of Category 2 (Pesticide evaluation report, Food Safety Commission of Japan (2014); Pesticide abstract (2015)). As above, effects on the liver and thyroid were observed from Category 1, and effects on blood system and kidney were found within a range of Category 2. Therefore, the substance was classified in Category 1 (liver, thyroid), Category 2 (blood system, kidney).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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